Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2700](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2700) → NMD — Oximeter, Tissue Saturation, Reprocessed

# NMD · Oximeter, Tissue Saturation, Reprocessed

_Cardiovascular · 21 CFR 870.2700 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NMD

## Overview

- **Product Code:** NMD
- **Device Name:** Oximeter, Tissue Saturation, Reprocessed
- **Regulation:** [21 CFR 870.2700](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2700)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K111007](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NMD/K111007.md) | MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE | Midwest Reprocessing Center, LLC | Jun 8, 2011 | SESE |
| [K100523](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NMD/K100523.md) | ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA | Hygia Health Services, Inc. | May 4, 2010 | SESE |

## Top Applicants

- Hygia Health Services, Inc. — 1 clearance
- Midwest Reprocessing Center, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NMD](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NMD)

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